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CELSION-201-17-201: Phase I-II Study Evaluating the Dosing, Safety, Efficacy and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Protocol No
CELSION-201-17-201
Principal Investigator
William Bradley
Phase
I/II
Summary
This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone
Description
The objective is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus NACT alone
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
Sub Category